Wiselink Group
Registration of Medical Devices for Clinical Trials
Thai FDA allows the import of Medical Devices for Clinical Trials and laboratory tests. Find out how you can do.
Medical Devices under Clinical test and not for sale in Thailand may be imported without FDA License
In some cases Medical Devices need to enter Thailand with the sole scope of Clinical Trials or laboratory Tests. This may be done in a single batch or in multiple import, without the burden of getting a Medical Device license in Thai FDA.
The process is shorter and less expensive, although the documentation, in case of consumables and notified Medical Devices, is quite similar. Of course, in case of Class II and Class I Medical Devices, a Clinical Trial in Thailand will be beneficial for a subsequent Commercial License Registration and make the full process easier.
In any case only a Thai Licensed Company (with an import license for Medical Devices) is authorized to ask for this procedure. The same Company shall be responsible for any damage caused by the device and shall certify the disposal (or reexport) of the tested equipment.
Wiselink Group services
Need to process Clinical Trials in Thailand for your Medical Devices? We can import your products and manage the test locally!
File Preparation and MOU with a Scientific Institute
To initiate Medical Device Clinical Trials in Thailand, we require a Power of Attorney (POA) from the manufacturer and a Memorandum of Understanding (MOU) with an accredited scientific institute. The MOU must specify the research scope, medical device specifications, testing protocols, and all relevant technical parameters.
Submission to Thai FDA of your Medical Device files
Upon receipt of the signed MOU and POA, we will compile a comprehensive documentation package that can be utilized for multiple Temporary Import License applications for your Medical Device (subject to Thai FDA authorization for each application). Following submission, the Import Authorization is typically issued within 14 working days for standard cases. The Thai FDA may request additional documentation if necessary.
Import and execution of Clinical Trial
Following receipt of the Medical Device Import Permit, we will submit the required shipping documentation (including packing list, commercial invoice, Airway Bill (AWB) or Bill of Lading (B/L)) to Thai FDA to obtain the License Per Invoice (LPI) - the final import authorization for the specific batch. Upon completion of testing, the medical device must either be returned to the country of origin or properly disposed of by an authorized waste management company.
OUR STANDARD PROPOSAL FOR the Registration of Medical Devices for Clinical Trials
Wiselink Group will serve as your Authorized Importer through Power of Attorney and will collaborate closely with your designated institute for Clinical Trials. Your products will be registered under Wiselink Group's name, acting as your marketing authorization holder (limited to clinical trials only).
We will require specific documentation for the Medical Device importation; in this case, Free Sale Certificate and other Standard Certifications are not required. This means your product will be authorized only for scientific purposes, not for commercial sale.
Wiselink Group will handle the application process and maintain communication with Thai FDA. After obtaining the Import Permit, we will manage customs clearance and coordinate delivery to your institute conducting the tests/trials.
After the product's use in trials, we will arrange return shipment if reusable, or handle disposal if consumable. We manage all aspects of the process on your behalf.
GENERAL GUIDELINES FOR TEMPORARY IMPORT of Medical Devices for Clinical Trials in Thailand
The waiver for importing medical devices can be obtained by applying at the Medical Device Control Division, or directly at a Customs Facility according to the cases below:
CASE 1, Submitting an application for an import waiver at the food and drug checkpoint at Customs during the import of equipment
This can be done by:
Physicians: A physician who is exempt from licensing requirements under Section 12 and declaration requirements under Section 16 as follows:
- For personal use
- For exhibition purposes
- For product demonstration
- For use in educational institutions
Agencies and Government agencies: For prevention, diagnosis, treatment, or rehabilitation by the Thai Red Cross Society or Government agencies. These organizations certify the quality, standards, efficiency and safety of imported medical devices.
Importing a medical device by a public or private medical facility with a certificate of introduction:
- Access to other medical devices approved by the Food and Drug Administration
- Import of new medical devices after overseas repair
- Import of medical devices for repair and subsequent return outside Thailand
- Repatriation of medical devices held by Customs Department
CASE 2, Submitting an application for import waiver at the Medical Device Control Division Office of the THAI FDA
For importing medical devices in the following cases:
- Medical devices that are components, fittings or parts used in medical device manufacturing or pharmaceutical production by licensed manufacturers in Thailand
- Import of medical devices for clinical research
- Medical devices for research, analysis or quality testing
- Import of donated medical devices
- Import of medical devices for sale to government agencies conducting preventive examinations